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CTRI Number  CTRI/2025/12/099170 [Registered on: 16/12/2025] Trial Registered Prospectively
Last Modified On: 15/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Medical Device
Surgical/Anesthesia
Preventive
Screening
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing intramarrow penetration with and without hyaluronic acid gel after gum surgery in patients with bone loss 
Scientific Title of Study   Comparative evaluation of open flap debridement with intramarrow penetration with and without Hyaluronic acid gel in the treatment of horizontal bone defect - clinico radiographic study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Praise Jose 
Designation  Post Graduate Student 
Affiliation  Periodontics 
Address  Department no. 4 , Periodontics and implantology Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218
Department no. 4,Periodontics and implantology Coorg Institute of Dental Sciences Maggula road Virajpet Kodagu 571218
Kodagu
KARNATAKA
571218
India 
Phone  07907195185  
Fax    
Email  praisjose@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Praise Jose 
Designation  Post Graduate Student 
Affiliation  Periodontics 
Address  Department no. 4,Periodontics and implantology Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218
Department no. 4,Periodontics and implantology Coorg Institute of Dental Sciences Maggula road Virajpet Kodagu 571218
Kodagu
KARNATAKA
571218
India 
Phone  07907195185  
Fax    
Email  praisjose@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr RADHIKA B 
Designation  PROFESSOR 
Affiliation  Periodontics 
Address  Department no. 4,Periodontics and implantology, Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218
Department no. 4,Periodontics and Implantology, Coorg Institute of Dental Sciences Maggula road Virajpet Kodagu 571218
Kodagu
KARNATAKA
571218
India 
Phone  9742096982  
Fax    
Email  radika_b24@yahoo.com  
 
Source of Monetary or Material Support  
Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 
 
Primary Sponsor  
Name  Dr Praise Jose 
Address  Department no.4 Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Praise Jose   Coorg institute of dental sciences  Department no. 4,Periodontics and implantology,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218
Kodagu
KARNATAKA 
07907195185

praisjose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  intramarrow penetration  open flap debridement with intramarrow penetration is done on 3mm below bone crest 
Comparator Agent  intramarrow penetration and hyaluronic acid gel  open flap debridement with intramarrow penetration and hyaluronic acid gel is done 3mm below bone crest. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Systemically healthy patient diagnosed with Stage II periodontitis, as defined by the 2017 World Workshop on the Classification of Periodontal and Peri-implant Diseases and Conditions. 
 
ExclusionCriteria 
Details  Ptients who has systemic diseases, pregnancy and habit of smoking are excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Bone fill in the horizontal bone loss area with intramarrow penetration and open flap debridement.  Bone fill in the horizontal bone loss area with intramarrow penetration and open flap debridement.At baseline and 3 month cbct is taken to evaluate bone fill. 
 
Secondary Outcome  
Outcome  TimePoints 
Bone fill in horizontal bone loss area with intramarrow penetration, hyaluronic acid gel and open flap debridement.   Bone fill in horizontal bone loss area with intramarrow penetration, hyaluronic acid gel and open flap debridement. Bone level is evaluated at baseline and 3 month with cbct. 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Periodontitis causes inflammation and destruction of the supporting alveolar bone and periodontal ligament. The periodontal disease alters the morphologic features of bone in addition to reducing height. It leads to various patterns of bone loss, of which horizontal and vertical bone loss are the most common bone destruction patterns. Performing Intramarrrow penetration (IMP) in the surgical site creates a close spatial correlation between angiogenesis and bone formation. The vessel-rich medullary opening space would facilitate capillary sprouting and enhance vascular access into the surgical site. A local increase in bone morphogenetic proteins and other growth factors from the injured cortical surface, endosteal area, and wounded vessel area can enhance further new bone formation. Open flap debridement (OFD) is used in various periodontal flap techniques with intrasulcular incisions and is used to treat bony defects. Hyaluronic acid (HA), a naturally occurring polysaccharide, is regarded as an essential component of the extracellular matrix in connective tissues of the human body. HA has been extensively used in dentistry, especially in periodontology, due to its bacteriostatic, fungistatic, anti-inflammatory, anti-edematous, osteoinductive, and pro-angiogenic properties.  These studies indicate that HA speeds up the wound healing process and promotes regeneration by maintaining the viability of oral fibroblasts, increasing their proliferative and migratory abilities, and enhancing the expression of genes encoding type III collagen .Thus, the present study aims to evaluate the efficacy of bone formation in horizontal bony defects with Intramarrow penetration clinically and radiographically with and without Hyaluronic acid.

 
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